Design and Rationale of the National Observational Multicentric Tunisian Registry of Hypertension: Protocol for Evaluating Hypertensive Patient Care in Clinical Practice.

BACKGROUND: This study was designed to evaluate the care of hypertensive patients in daily clinical practice in public and private centers in all Tunisian regions. OBJECTIVE: This study will provide us an overview of hypertension (HTN) management in Tunisia and the degree of adherence of practitioners to international recommendations. METHODS: This is a national observational cross-sectional multicenter study that will include patients older than 18 years with HTN for a duration of 4 weeks, managed in the public sector from primary and secondary care centers as well as patients managed in the private sector. Every participating patient signed a consent form. The study will exclude patients undergoing dialysis. The parameters that will be evaluated are demographic and anthropometric data, lifestyle habits, blood pressure levels, lipid profiles, treatment, and adherence to treatment. The data are collected via the web interface in the Dacima Clinical Suite. RESULTS: The study began on April 15, 2019 and ended on May 15, 2019. During this period, we included 25,890 patients with HTN. Data collection involved 321 investigators from 24 Tunisian districts. The investigators were doctors working in the private and public sectors. CONCLUSIONS: Observational studies are extremely useful in improving the management of HTN in developing countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT04013503; https://clinicaltrials.gov/ct2/show/NCT04013503. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21878.

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

BACKGROUND: Coronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries. OBJECTIVE: The aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia. METHODS: We will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis. RESULTS: In this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022. CONCLUSIONS: This study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region. TRIAL REGISTRATION: Clinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/24595.

Epidemiologic features and management of hypertension in Tunisia, the results from the Hypertension National Registry (NaTuRe HTN).

BACKGROUND: Hypertension is the leading cause of morbi-mortality in our country. Thus, we conducted this national survey on hypertension to analyze the profile of the Tunisian hypertensive patient and to assess the level of blood pressure control. METHODS: Nature HTN is an observational multicentric survey, including hypertensive individuals and consulting their doctors during the period of the study. Blood pressure measurements were conducted during consultation, using a standardized auscultatory or oscillometric sphygmomanometer after at least 15 min of rest. The diagnosis of new hypertension is based on the 2018 ESC/ESH criteria. The primary endpoint of our study was uncontrolled hypertension defined by a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. RESULTS: Three hundred twenty-one investigators participated in the study. We enrolled 25,890 patients with a female predominance (Sex ratio, 1.21) and an average age of 64.4 ± 12.2 years. Most individuals were treated in the public sector (74%), 39.4% of patients were diabetic, 25.8% were obese, 44.6% were overweight and 14% were smokers. Hypertension was controlled in 51.7% of cases if we consider 140/90 as a BP target, and only in 18.6% if we consider 130/80 as a target. The independent predictors of uncontrolled blood pressure were male sex (OR = 1.09, 95%CI [1.02-1.16]), age > 65 year-old (OR = 1.07, 95% CI[1.01-1.13], diabetes (OR = 1.18, 95% CI [1.11-1.25], Smoking (OR = 1.15, 95% CI [1.05-1.25]), Obesity (OR = 1.14, 95% CI[1.07-1.21]), management in public sector (OR = 1.25, 95% CI [1.16-1.34]), and Heart rate > 80 bpm (OR = 1.59, 95% CI [1.48-1.71]). Contrarily, high educational level (OR = 0.9, 95% CI [0.84-0.97], absence of history of coronary disease (OR = 0.86, 95% CI [0.8-0.93]), salt restriction (OR = 0.48, 95% CI [0.45-0.51]), drug compliance (OR = 0.57, 95% CI[0.52-0.61]), and regular physical activity (OR = 0.77, 95% CI[0.71-0.84]) are strong predictors of blood pressure control. CONCLUSION: NaTuRe HTN showed that blood pressure control was reached in more than half of the Tunisian people. The control remains low in patients with high cardiovascular profiles and in those treated in the public sector. A national health program based on therapeutic education, regular control and continuous support to the public institutions is needed to decrease the burden of hypertension incidence rate.

Efficacy and safety of Parecoxib for prevention of catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: Prospective randomised trial.

BACKGROUND AND AIMS: Catheter-related bladder discomfort (CRBD) is the urge to void or discomfort in the suprapubic region secondary to an indwelling urinary catheter. We aimed to evaluate the safety and efficacy of single-dose of intravenous parecoxib in reducing the incidence and severity of CRBD in patients undergoing transurethral resection of bladder tumor (TURBT). METHODS: Sixty-one adult patients, American Society of Anesthesiologists physical status I or II, undergoing elective TURBT under spinal anaesthesia, were randomly allocated to receive 40 mg of IV parecoxib (group P; n = 29) or an equal volume of normal saline (control group C; n = 32). CRBD was graded as none, mild, moderate, and severe. Between-group comparisons were made for the incidence and severity of CRBD, postoperative Visual analog scales (VAS), rescue analgesia equirements, and occurrence of adverse events. Statistical analysis done with the Mann-Whitney U-test and Fisher's Exact Test. A P value of ≤ 0.05 was considered statistically significant. RESULTS: Parecoxib significantly reduced the incidence and severity of CRBD at 2, 4, 6, and 12 hours postoperatively compared to placebo (P < 0.05). Median pain VAS scores were lower in the P group at all times except the first hour. Rescue analgesia was given to more patients in group C (16/32, 50%) than in group P (1/29) (P < 0.001). None of the patients who received parecoxib experienced an adverse event. CONCLUSION: A single intravenous injection of parecoxib is safe and effective in decreasing the incidence and severity of CRBD in patients undergoing TURBT. TRIAL REGISTRATION IDENTIFIER: NCT02729935(www.clinicaltrials.gov).