deliVERy of optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria study: Rationale and design of a randomized clinical trial.

BACKGROUND: Blood pressure (BP) control among treated patients in Africa is very suboptimal, with low levels of combination therapy use and therapeutic inertia being among the major barriers to effective control of hypertension. The VERONICA-Nigeria study aims to evaluate, among Black African adults with hypertension, the effectiveness and safety of a triple pill-based treatment protocol compared to Nigeria hypertension treatment protocol (standard care protocol) for the treatment of hypertension. METHODS: This study involves a randomized, parallel-group and open-label trial. Adults with uncontrolled hypertension (n = 300), untreated or receiving monotherapy, with no contraindication to study treatments will be randomly assigned 1:1 to treatment with a triple pill based-treatment protocol or standard care protocol. Follow-up is for 6 months, with interim follow up visits at month 1, 2, and 3. In a noncomparative extension treatment period, participants completing the 6 months randomized period and on ≤3 BP-lowering drugs will receive treatment with the triple pill-based treatment protocol for 12 months. The primary outcome is change in home mean SBP from baseline to month 6, and key secondary efficacy outcome is percentage of participants with clinic BP <140/90 mmHg at month 6. The primary safety outcome is discontinuation of trial treatment due to adverse events from randomization to month 6. Economic evaluation will be conducted to assess the cost-effectiveness of the triple pill-based treatment protocol, and process evaluation will be conducted to understand the context in which the trial was conducted, implementation of the trial and interventions and mechanisms of effect, and potential barriers and facilitators to implementing the intervention in clinical practice. CONCLUSION: The VERONICA-Nigeria trial will provide evidence of effectiveness and safety of the triple-based treatment protocol for the pharmacological management of hypertension, in Black African adults. TRIAL REGISTRATION: PACTR202107579572114.

Interventions and contextual factors to improve retention in care for patients with hypertension in primary care: Hermeneutic systematic review.

BACKGROUND: Regular engagement over time in hypertension care, or retention, is a crucial but understudied step in optimizing patient outcomes. This systematic review leverages a hermeneutic methodology to identify, evaluate, and quantify the effects of interventions and contextual factors for improving retention for patients with hypertension. METHODS: We searched for articles that were published between 2000 and 2022 from multiple electronic databases, including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, and WHO International Trials Registry. We followed the latest version of the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline to report the findings for this review. We also synthesized the findings using a hermeneutic methodology for systematic reviews, which used an iterative process to review, integrate, analyze, and interpret evidence. RESULTS: From 4686 screened titles and abstracts, 18 unique studies from 9 countries were identified, including 10 (56%) randomized controlled trials (RCTs), 3 (17%) cluster RCTs, and 5 (28%) non-RCT studies. The number of participants ranged from 76 to 1562. The overall mean age range was 41-67 years, and the proportion of female participants ranged from 0% to 100%. Most (n = 17, 94%) studies used non-physician personnel to implement the proposed interventions. Fourteen studies (78%) implemented multilevel combinations of interventions. Education and training, team-based care, consultation, and Short Message Service reminders were the most common interventions tested. CONCLUSIONS: This review presents the most comprehensive findings on retention in hypertension care to date and fills the gaps in the literature, including the effectiveness of interventions, their components, and contextual factors. Adaptation of and implementing HIV care models, such differentiated service delivery, may be more effective and merit further study. REGISTRATION: CRD42021291368. PROTOCOL REGISTRATION: PROSPERO 2021 CRD42021291368. Available at: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=291368.

On-demand mobile hypertension training for primary health care workers in Nigeria: a pilot study.

BACKGROUND: Only one out of every ten Nigerian adults with hypertension has their blood pressure controlled. Health worker training is essential to improve hypertension diagnosis and treatment. In-person training has limitations that mobile, on-demand training might address. This pilot study evaluated a self-paced, case-based, mobile-optimized online training to diagnose and manage hypertension for Nigerian health workers. METHODS: Twelve hypertension training modules were developed, based on World Health Organization and Nigerian guidelines. After review by local academic and government partners, the course was piloted by Nigerian health workers at government-owned primary health centers. Primary care physician, nurse, and community health worker participants completed the course on their own smartphones. Before and after the course, hypertension knowledge was evaluated with multiple-choice questions. Learners provided feedback by responding to questions on a Likert scale. RESULTS: Out of 748 users who sampled the course, 574 enrolled, of whom 431 (75%) completed the course. The average pre-test score of completers was 65.4%, which increased to 78.2% on the post-test (P < 0.001, paired t-test). Health workers who were not part of existing hypertension control programs had lower pre-test scores and larger score gains. Most participants (96.1%) agreed that the training was applicable to their work, and nearly all (99.8%) agreed that they enjoyed the training. CONCLUSIONS: An on-demand mobile digital hypertension training increases knowledge of hypertension management among Nigerian health workers. If offered at scale, such courses can be a tool to build health workforce capacity through initial and refresher training on current clinical guidelines in hypertension and other chronic diseases in Nigeria as well as other countries.

The Pandemic of Coronary Artery Disease in the Sub-Saharan Africa: What Clinicians Need to Know.

PURPOSE OF REVIEW: Cardiovascular diseases (CVDs) are a leading cause of morbidity and mortality globally with an accelerated increase in CVD­related death in Africa and other low­middle­income countries. This review is aimed at highlighting the burden of coronary artery disease CAD, its peculiarities as well as challenges of management in sub-Saharan Africa. RECENT FINDINGS: Recent data revealed a shift from high incidence of CVDs associated with poverty and malnutrition (such as rheumatic heart disease) initially, which are now falling, to rising incidence of other non-communicable CVDs (such as hypertension, coronary artery disease (CAD), and heart failure). Africa disproportionately bears the brunt of CVD burden and has one of the highest risks of dying from non-communicable diseases (NCDs) worldwide, which is projected to supersede communicable diseases in the future. Previous studies have shown that CAD was rare among Africans. Those studies conducted in Africa in the 1940s-1960s reported that Black Africans were almost immune to developing CAD and were even thought to have specific genetic make-up protecting them from CAD. However, the continent is now experiencing a steady rise in the prevalence of CAD associated with severe disease burden, compared to other regions of the world. The changes seen have been attributed to the current epidemiological transition with increase in CVD risk factors that are poorly controlled, lack of awareness as well as the poor health facilities to tackle the menace of the disease. The Global Burden of Disease (GBD) estimates have also shown that over the past three decades the highest contribution to CVD burden in Africa is attributed to atherosclerotic diseases, with 71.4, 37.7, and 154% increases in the burden of ischemic heart disease, stroke, and peripheral artery disease respectively. There is a steady increase of CAD prevalence in Africa as a result of increase in CV risk factors. Hypertension, obesity, diabetes, dyslipidemia, and cigarette smoking are the rapidly rising risk factors for CAD on the continent. Africa also faces challenges in diagnosis and management of CAD. There is need for increased public and health personnel awareness on prevention and control of commonly identifiable risk factors, provision of prehospital emergency services, and provision of modern therapeutic facilities for treatment of CAD including reperfusion therapy. These are priority areas where efforts could be intensified in the future with potential to improve the current rate of progress of the disease on the continent.

Clinical characteristics and treatment patterns of pregnant women with hypertension in primary care in the Federal Capital Territory of Nigeria: cross-sectional results from the hypertension treatment in Nigeria Program.

BACKGROUND: Hypertensive disorders of pregnancy, including hypertension, are a leading cause of maternal mortality in Nigeria. However, there is a paucity of data on pregnant women with hypertension who receive care in primary health care facilities. This study presents the results from a cross-sectional analysis of pregnant women enrolled in the Hypertension Treatment in Nigeria Program which is aimed at integrating and strengthening hypertension care in primary health care centres. METHODS: A descriptive analysis of the baseline results from the Hypertension Treatment in Nigeria Program was performed. Baseline blood pressures, treatment and control rates of pregnant women were analysed and compared to other adult women of reproductive age. A complete case analysis was performed, and a two-sided p value < 0.05 was considered statistically significant. RESULTS: Between January 2020 to October 2022, 5972 women of reproductive age were enrolled in the 60 primary healthcare centres participating in the Hypertension Treatment in Nigeria Program and 112 (2%) were pregnant. Overall mean age (SD) was 39.6 years (6.3). Co-morbidities were rare in both groups, and blood pressures were similar amongst pregnant and non-pregnant women (overall mean (SD) first systolic and diastolic blood pressures were 157.4 (20.6)/100.7 (13.6) mm Hg and overall mean (SD) second systolic and diastolic blood pressures were 151.7 (20.1)/98.4 (13.5) mm Hg). However, compared to non-pregnant women, pregnant women had a higher rate of newly diagnosed hypertension (65.2% versus 54.4% p = 0.02) and lower baseline walk-in treatment (32.1% versus 42.1%, p = 0.03). The control rate was numerically lower among pregnant patients (6.3% versus 10.2%, p = 0.17), but was not statistically significant. Some pregnant patients (8.3%) were on medications contraindicated in pregnancy, and none of the pregnant women were on aspirin for primary prevention of preeclampsia. CONCLUSIONS: These findings indicate significant gaps in care and important areas for future studies to improve the quality of care and outcomes for pregnant women with hypertension in Nigeria, a country with the highest burden of maternal mortality globally.

Facilitators and barriers to optimal home blood pressure management in patients with hypertensive disorders of pregnancy in a tertiary care facility in Abuja, Nigeria: a qualitative research study.

BACKGROUND: Nigeria has one of the highest burdens of maternal deaths globally, and hypertensive disorders of pregnancy (HDP) are the leading cause of maternal morbidity and mortality in the country. There is a significant implementation gap in utilizing evidence-based practices for the management of HDP in Nigeria. This study evaluated facilitators and barriers to implementing a home blood pressure monitoring program to improve management of HDP. METHODS: From August 2022 to September 2022, we conducted 15 semi-structured, key informant interviews and 4 focus group discussions among patients, health care workers, and administrators at University of Abuja Teaching Hospital (UATH), a tertiary care centre in Nigeria. The study used the Consolidated Framework for Implementation Research to assess five domains: individual characteristics, inner and outer settings, intervention characteristics, and process of implementation. Audio files were transcribed, and data were analysed using a combination of inductive and deductive approaches. We also conducted 32 brief surveys on the participants to assess acceptability, appropriateness, and feasibility of a blood pressure monitoring program. RESULTS: The study sample consisted of healthcare workers (n=22) including specialists in cardiology, obstetrics and gynaecology, maternal-foetal medicine, nurses/midwives and resident doctors as well as patients (n=10). Mean (SD) age was 39.5 (10.9), and 78% were female. Participants identified facilitators including the perceived simplicity of home blood pressure monitoring program, high burden of HDP, and availability of a multi-disciplinary team of healthcare professionals with expertise in HDP management. Barriers identified were cost, limited knowledge of HDP amongst patients, limited transportation networks, inconsistent management protocols, and inadequate manpower and facilities. Survey results indicated that between 81% and 88% of participants reported that a blood pressure monitoring program would be acceptable, 56%-72% reported that it would be appropriate, and 47%-69% reported that it would be feasible. CONCLUSION: This study identified facilitators and barriers while highlighting key implementation strategies to leverage and effectively address these respectively to enable successful implementation of a home blood pressure monitoring program. It also demonstrated that a home blood pressure monitoring program was considered acceptable, appropriate and feasible among respondents interviewed at UATH.

Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans.

BACKGROUND: The prevalence of hypertension among black African patients is high, and these patients usually need two or more medications for blood-pressure control. However, the most effective two-drug combination that is currently available for blood-pressure control in these patients has not been established. METHODS: In this randomized, single-blind, three-group trial conducted in six countries in sub-Saharan Africa, we randomly assigned 728 black patients with uncontrolled hypertension (≥140/90 mm Hg while the patient was not being treated or was taking only one antihypertensive drug) to receive a daily regimen of 5 mg of amlodipine plus 12.5 mg of hydrochlorothiazide, 5 mg of amlodipine plus 4 mg of perindopril, or 4 mg of perindopril plus 12.5 mg of hydrochlorothiazide for 2 months. Doses were then doubled (10 and 25 mg, 10 and 8 mg, and 8 and 25 mg, respectively) for an additional 4 months. The primary end point was the change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months. RESULTS: The mean age of the patients was 51 years, and 63% were women. Among the 621 patients who underwent 24-hour blood-pressure monitoring at baseline and at 6 months, those receiving amlodipine plus hydrochlorothiazide and those receiving amlodipine plus perindopril had a lower 24-hour ambulatory systolic blood pressure than those receiving perindopril plus hydrochlorothiazide (between-group difference in the change from baseline, -3.14 mm Hg; 95% confidence interval [CI], -5.90 to -0.38; P = 0.03; and -3.00 mm Hg; 95% CI, -5.8 to -0.20; P = 0.04, respectively). The difference between the group receiving amlodipine plus hydrochlorothiazide and the group receiving amlodipine plus perindopril was -0.14 mm Hg (95% CI, -2.90 to 2.61; P=0.92). Similar differential effects on office and ambulatory diastolic blood pressures, along with blood-pressure control and response rates, were apparent among the three groups. CONCLUSIONS: These findings suggest that in black patients in sub-Saharan Africa, amlodipine plus either hydrochlorothiazide or perindopril was more effective than perindopril plus hydrochlorothiazide at lowering blood pressure at 6 months. (Funded by GlaxoSmithKline Africa Noncommunicable Disease Open Lab; CREOLE ClinicalTrials.gov number, NCT02742467.).

High prevalence of non-dipping patterns among Black Africans with uncontrolled hypertension: a secondary analysis of the CREOLE trial.

BACKGROUND: Dipping of blood pressure (BP) at night is a normal physiological phenomenon. However, a non-dipping pattern is associated with hypertension mediated organ damage, secondary forms of hypertension and poorer long-term outcome. Identifying a non-dipping pattern may be useful in assessing risk, aiding the decision to investigate for secondary causes, initiating treatment, assisting decisions on choice and timing of antihypertensive therapy, and intensifying salt restriction. OBJECTIVES: To estimate the prevalence and factors associated with non-dipping pattern and determine the effect of 6 months of three antihypertensive regimens on the dipping pattern among Black African hypertensive patients. METHODS: This was a secondary analysis of the CREOLE Study which was a randomized, single blind, three-group trial conducted in 10 sites in 6 Sub-Saharan African countries. The participants were 721 Black African patients, aged between 30 and 79 years, with uncontrolled hypertension and a baseline 24-h ambulatory blood pressure monitoring (ABPM). Dipping was calculated from the average day and average night systolic blood pressure measures. RESULTS: The prevalence of non-dipping pattern was 78% (564 of 721). Factors that were independently associated with non-dipping were: serum sodium > 140 mmol/l (OR = 1.72, 95% CI 1.17-2.51, p-value 0.005), a higher office systolic BP (OR = 1.03, 95% CI 1.01-1.05, p-value 0.003) and a lower office diastolic BP (OR = 0.97, 95% CI 0.95-0.99, p-value 0.03). Treatment allocation did not change dipping status at 6 months (McNemar's Chi2 0.71, p-value 0.40). CONCLUSION: There was a high prevalence of non-dipping among Black Africans with uncontrolled hypertension. ABPM should be considered more routinely in Black Africans with uncontrolled hypertension, if resources permit, to help personalise therapy. Further research is needed to understand the mechanisms and causes of non-dipping pattern and if targeting night-time BP improves clinical outcomes. Trial registration ClinicalTrials.gov (NCT02742467).

Capacity and site readiness for hypertension control program implementation in the Federal Capital Territory of Nigeria: a cross-sectional study.

BACKGROUND: Nigeria faces an increase in the burden of non-communicable diseases (NCDs), including cardiovascular diseases (CVDs), leading to an estimated 29% of all deaths in the country. Nigeria has an estimated hypertension prevalence ranging from 25 to 40% of her adult population. Despite this high burden, awareness (14-30%), treatment (< 20%), and control (9%) rates of hypertension are low in Nigeria. Against this backdrop, we sought to perform capacity and readiness assessments of public Primary Healthcare Centers (PHCs) to inform Nigeria's system-level hypertension control program's implementation and adaptation strategies. METHODS: The study employed a multi-stage sampling to select 60 from the 243 PHCs in the Federal Capital Territory (FCT) of Nigeria. The World Health Organization (WHO) Service Availability and Readiness Assessment was adapted to focus on hypertension diagnosis and treatment and was administered to PHC staff from May 2019 - October 2019. Indicator scores for general and cardiovascular service readiness were calculated based on the proportion of sites with available amenities, equipment, diagnostic tests, and medications. RESULTS: Median (interquartile range [IQR]) number of full-time staff was 5 (3-8), and were predominantly community health extension workers (median = 3 [IQR 2-5]). Few sites (n = 8; 15%) received cardiovascular disease diagnosis and management training within the previous 2 years, though most had sufficient capacity for screening (n = 58; 97%), diagnosis (n = 56; 93%), and confirmation (n = 50; 83%) of hypertension. Few PHCs had guidelines (n = 7; 13%), treatment algorithms (n = 3; 5%), or information materials (n = 1; 2%) for hypertension. Most sites (n = 55; 92%) had one or more functional blood pressure apparatus. All sites relied on paper records, and few had a functional computer (n = 10; 17%) or access to internet (n = 5; 8%). Despite inclusion on Nigeria's essential medicines list, 35 (59%) PHCs had zero 30-day treatment regimens of any blood pressure-lowering medications in stock. CONCLUSIONS: This first systematic assessment of capacity and readiness for a system-level hypertension control program within the FCT of Nigeria demonstrated implementation feasibility based on the workforce, equipment, and paper-based information systems, but a critical need for essential medicine supply strengthening, health-worker training, and protocols for hypertension treatment and control in Nigeria.

May Measurement Month 2017: screening for hypertension in Nigeria-Sub-Saharan Africa.

Hypertension and its complications are now responsible for about a quarter of emergency medical admissions in urban hospitals in Nigeria. It is the commonest risk factor for stroke, heart failure, chronic kidney disease, and dementia. Furthermore, high blood pressure is the commonest cause of sudden unexpected natural death in the country. Regrettably, the rate of awareness, treatment, and control is abysmally low in the country and in many parts of the world. May Measurement Month (MMM) is a global initiative of the International Society of Hypertension aimed at raising awareness of high blood pressure (BP) and to act as a temporary solution to the lack of screening programs worldwide. An opportunistic cross-sectional survey of volunteers aged ≥18 years was carried out in May 2017. Blood pressure measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. A total of 19 904 individuals with a mean age of 40.9 years, were screened during MMM17. After multiple imputation, 6709 (36.2%) had hypertension. Of individuals not receiving anti-hypertensive medication, 4140 (25.9%) were found to have hypertension. Of individuals receiving anti-hypertensive medication, 1449 (58.8%) had uncontrolled BP. MMM17 was one of the largest BP screening campaigns undertaken in Nigeria. A significant number of the participants were identified with hypertension (but not on any treatment) and uncontrolled BP despite being treated. These results suggest that opportunistic screening can identify significant numbers with raised BP.

Rationale and design of the comparison of 3 combination therapies in lowering blood pressure in black Africans (CREOLE study): 2 × 3 factorial randomized single-blind multicenter trial.

BACKGROUND: Current hypertension guidelines recommend the use of combination therapy as first-line treatment or early in the management of hypertensive patients. Although there are many possible combinations of blood pressure(BP)-lowering therapies, the best combination for the black population is still a subject of debate because no large randomized controlled trials have been conducted in this group to compare the efficacy of different combination therapies to address this issue. METHODS: The comparison of 3 combination therapies in lowering BP in the black Africans (CREOLE) study is a randomized single-blind trial that will compare the efficacy of amlodipine plus hydrochlorothiazide versus amlodipine plus perindopril and versus perindopril plus hydrochlorothiazide in blacks residing in sub-Saharan Africa (SSA). Seven hundred two patients aged 30-79 years with a sitting systolic BP of 140 mm Hg and above, and less than 160 mm Hg on antihypertensive monotherapy, or sitting systolic BP of 150 mm Hg and above, and less than 180 mm Hg on no treatment, will be centrally randomized into any of the 3 arms (234 into each arm). The CREOLE study is taking place in 10 sites in SSA, and the primary outcome measure is change in ambulatory systolic BP from baseline to 6 months. The first patient was randomized in June 2017, and the trial will be concluded by 2019. CONCLUSIONS: The CREOLE trial will provide unique information as to the most efficacious 2-drug combination in blacks residing in SSA and thereby inform the development of clinical guidelines for the treatment of hypertension in this subregion.

Clinical Outcomes in 3343 Children and Adults With Rheumatic Heart Disease From 14 Low- and Middle-Income Countries: Two-Year Follow-Up of the Global Rheumatic Heart Disease Registry (the REMEDY Study).

BACKGROUND: There are few contemporary data on the mortality and morbidity associated with rheumatic heart disease or information on their predictors. We report the 2-year follow-up of individuals with rheumatic heart disease from 14 low- and middle-income countries in Africa and Asia. METHODS: Between January 2010 and November 2012, we enrolled 3343 patients from 25 centers in 14 countries and followed them for 2 years to assess mortality, congestive heart failure, stroke or transient ischemic attack, recurrent acute rheumatic fever, and infective endocarditis. RESULTS: Vital status at 24 months was known for 2960 (88.5%) patients. Two-thirds were female. Although patients were young (median age, 28 years; interquartile range, 18-40), the 2-year case fatality rate was high (500 deaths, 16.9%). Mortality rate was 116.3/1000 patient-years in the first year and 65.4/1000 patient-years in the second year. Median age at death was 28.7 years. Independent predictors of death were severe valve disease (hazard ratio [HR], 2.36; 95% confidence interval [CI], 1.80-3.11), congestive heart failure (HR, 2.16; 95% CI, 1.70-2.72), New York Heart Association functional class III/IV (HR, 1.67; 95% CI, 1.32-2.10), atrial fibrillation (HR, 1.40; 95% CI, 1.10-1.78), and older age (HR, 1.02; 95% CI, 1.01-1.02 per year increase) at enrollment. Postprimary education (HR, 0.67; 95% CI, 0.54-0.85) and female sex (HR, 0.65; 95% CI, 0.52-0.80) were associated with lower risk of death. Two hundred and four (6.9%) patients had new congestive heart failure (incidence, 38.42/1000 patient-years), 46 (1.6%) had a stroke or transient ischemic attack (8.45/1000 patient-years), 19 (0.6%) had recurrent acute rheumatic fever (3.49/1000 patient-years), and 20 (0.7%) had infective endocarditis (3.65/1000 patient-years). Previous stroke and older age were independent predictors of stroke/transient ischemic attack or systemic embolism. Patients from low- and lower-middle-income countries had significantly higher age- and sex-adjusted mortality than patients from upper-middle-income countries. Valve surgery was significantly more common in upper-middle-income than in lower-middle- or low-income countries. CONCLUSIONS: Patients with clinical rheumatic heart disease have high mortality and morbidity despite being young; those from low- and lower-middle-income countries had a poorer prognosis associated with advanced disease and low education. Programs focused on early detection and the treatment of clinical rheumatic heart disease are required to improve outcomes.

Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis.

BACKGROUND: Tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered. We evaluated the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis. METHODS: Using a 2-by-2 factorial design, we randomly assigned 1400 adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M. indicus pranii or placebo, administered in five injections over the course of 3 months. Two thirds of the participants had concomitant human immunodeficiency virus (HIV) infection. The primary efficacy outcome was a composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. RESULTS: There was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo (23.8% and 24.5%, respectively; hazard ratio, 0.95; 95% confidence interval [CI], 0.77 to 1.18; P=0.66) or between those who received M. indicus pranii immunotherapy and those who received placebo (25.0% and 24.3%, respectively; hazard ratio, 1.03; 95% CI, 0.82 to 1.29; P=0.81). Prednisolone therapy, as compared with placebo, was associated with significant reductions in the incidence of constrictive pericarditis (4.4% vs. 7.8%; hazard ratio, 0.56; 95% CI, 0.36 to 0.87; P=0.009) and hospitalization (20.7% vs. 25.2%; hazard ratio, 0.79; 95% CI, 0.63 to 0.99; P=0.04). Both prednisolone and M. indicus pranii, each as compared with placebo, were associated with a significant increase in the incidence of cancer (1.8% vs. 0.6%; hazard ratio, 3.27; 95% CI, 1.07 to 10.03; P=0.03, and 1.8% vs. 0.5%; hazard ratio, 3.69; 95% CI, 1.03 to 13.24; P=0.03, respectively), owing mainly to an increase in HIV-associated cancer. CONCLUSIONS: In patients with tuberculous pericarditis, neither prednisolone nor M. indicus pranii had a significant effect on the composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. (Funded by the Canadian Institutes of Health Research and others; IMPI ClinicalTrials.gov number, NCT00810849.).

Symptoms and Signs of Heart Failure at Admission and Discharge and Outcomes in the Sub-Saharan Acute Heart Failure (THESUS-HF) Registry.

BACKGROUND: Symptoms and signs of heart failure (HF) are the most common reasons for admission to hospital for acute HF (AHF) and are used routinely throughout admission to assess the severity of disease and response to therapy. METHODS AND RESULTS: The data were collected in The Sub-Saharan Africa Survey on Heart Failure (THESUS-HF) study, a prospective, multicenter, observational survey of AHF from 9 countries in sub-Saharan Africa. A total of 1006 patients, ≥12 years of age, hospitalized for AHF were recruited. Symptoms and signs of HF and changes in dyspnea and well-being, relative to admission, were assessed at entry and on days 1, 2, and 7 (or on discharge if earlier) and included oxygen saturation, degree of edema and rales, body weight, and level of orthopnea. The patient determined dyspnea and general well-being, whereas the physician determined symptoms and signs of HF, as well as improvements in vital sign measurement, throughout the admission. After multivariable adjustment, baseline rales and changes to day 7 or discharge in general well-being predicted death or HF hospitalization through day 60, and baseline orthopnea, edema, rales, oxygen saturation, and changes to day 7 or on discharge in respiratory rate and general well-being were predictive of death through day 180. CONCLUSIONS: In AHF patients in sub-Saharan Africa, symptoms and signs of HF improve throughout admission, and simple assessments, including edema, rales, oxygen saturation, respiratory rate, and asking the patient about general well-being, are valuable tools in patients' clinical assessment.

Characteristics, complications, and gaps in evidence-based interventions in rheumatic heart disease: the Global Rheumatic Heart Disease Registry (the REMEDY study).

AIMS: Rheumatic heart disease (RHD) accounts for over a million premature deaths annually; however, there is little contemporary information on presentation, complications, and treatment. METHODS AND RESULTS: This prospective registry enrolled 3343 patients (median age 28 years, 66.2% female) presenting with RHD at 25 hospitals in 12 African countries, India, and Yemen between January 2010 and November 2012. The majority (63.9%) had moderate-to-severe multivalvular disease complicated by congestive heart failure (33.4%), pulmonary hypertension (28.8%), atrial fibrillation (AF) (21.8%), stroke (7.1%), infective endocarditis (4%), and major bleeding (2.7%). One-quarter of adults and 5.3% of children had decreased left ventricular (LV) systolic function; 23% of adults and 14.1% of children had dilated LVs. Fifty-five percent (n = 1761) of patients were on secondary antibiotic prophylaxis. Oral anti-coagulants were prescribed in 69.5% (n = 946) of patients with mechanical valves (n = 501), AF (n = 397), and high-risk mitral stenosis in sinus rhythm (n = 48). However, only 28.3% (n = 269) had a therapeutic international normalized ratio. Among 1825 women of childbearing age (12-51 years), only 3.6% (n = 65) were on contraception. The utilization of valvuloplasty and valve surgery was higher in upper-middle compared with lower-income countries. CONCLUSION: Rheumatic heart disease patients were young, predominantly female, and had high prevalence of major cardiovascular complications. There is suboptimal utilization of secondary antibiotic prophylaxis, oral anti-coagulation, and contraception, and variations in the use of percutaneous and surgical interventions by country income level.

Prognostic significance of ECG abnormalities for mortality risk in acute heart failure: insight from the Sub-Saharan Africa Survey of Heart Failure (THESUS-HF).

OBJECTIVE: The aim of this study was to assess the predictive utility of 12-lead electrocardiogram (ECG) abnormalities among Africans with acute heart failure (HF). METHODS AND RESULTS: We used the Sub-Saharan Africa Survey of Heart Failure, a multicenter prospective cohort study of 1,006 acute HF patients, and regression models to relate baseline ECG findings to all-cause mortality and readmission during a 6-month follow-up period. Of 814 ECGs available, 523 (49.0% male) were obtained within 15 days of admission, among which 97.7% showed abnormalities. Mean age was 52.0 years and median follow-up was 180 days, with 77 deaths (Kaplan-Meier 17.5%) through day 180 and 63 patients with death or readmission to day 60. QRS width, QT duration, bundle branch block, and ischemic changes were not associated with outcomes. Increasing ventricular rate was associated with increasing risk of both outcomes (hazard ratio [HR] 1.07 per 5 beats/min increase for 60-day death or readmission, 95% confidence interval [CI] 1.02-1.12; P = .0047), and the presence of sinus rhythm was associated with lower risk (HR 0.58, 95% CI 0.34-0.97; P = .0385). There was a strong association between survival and heart rate in patients in sinus rhythm, with heart rate >119 beats/min conveying the worst mortality risk. CONCLUSIONS: ECG abnormalities are almost universal among Africans with acute HF, which may add to the immediate diagnosis of patients presenting with dyspnea. Although some ECG findings have prognostic value for risk of adverse outcomes, most of them are nonspecific and add little to the risk stratification of these patients.