Treatment of early hypertension among persons living with HIV in Haiti: Protocol for a randomized controlled trial
| Autor: | Eliezer Dade, Margaret L. McNairy, Vanessa Rouzier, Stephano St-Preux, Collette Guiteau, Jean W. Pape, Jean Lookens Pierre, Suzanne Oparil, Lily D. Yan, Miranda Metz |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
RNA viruses
Statistics as Topic Human immunodeficiency virus (HIV) Blood Pressure HIV Infections Disease Cardiovascular Medicine medicine.disease_cause Pathology and Laboratory Medicine Vascular Medicine law.invention Study Protocol Medical Conditions Randomized controlled trial Immunodeficiency Viruses law Antihypertensive Drug Therapy Outcome Assessment Health Care Medicine and Health Sciences Medicine Multidisciplinary Pharmaceutics Drugs Cardiovascular Therapy Arms Medical Microbiology Cardiovascular Diseases Viral Pathogens Viruses Hypertension Pathogens Anatomy medicine.drug medicine.medical_specialty Science MEDLINE Cardiology Microbiology Prehypertension Drug Therapy Internal medicine Retroviruses Humans Amlodipine Adverse effect Microbial Pathogens Pharmacology Treatment Guidelines Health Care Policy business.industry Lentivirus Organisms Biology and Life Sciences HIV Cardiovascular Disease Risk Haiti Health Care Blood pressure Who guidelines Body Limbs Sample Size business Antihypertensives Follow-Up Studies |
| Zdroj: | PLoS ONE PLoS ONE, Vol 16, Iss 8, p e0254740 (2021) PLoS ONE, Vol 16, Iss 8 (2021) |
| ISSN: | 1932-6203 |
| Popis: | Background People living with HIV (PLWH) are at increased risk of cardiovascular disease (CVD) and death, with greater burdens of both HIV and CVD in lower-middle income countries. Treating prehypertension in PLWH may reduce progression to hypertension, CVD risk and potentially mortality. However, no trial has evaluated earlier blood pressure treatment for PLWH. We propose a randomized controlled trial to assess the feasibility, benefits, and risks of initiating antihypertensive treatment among PLWH with prehypertension, comparing prehypertension treatment to standard of care following current WHO guidelines. Methods A total of 250 adults 18–65 years and living with HIV (PLWH) with viral suppression in the past 12 months, who have prehypertension will be randomized to prehypertension treatment versus standard of care. Prehypertension is defined as having a systolic blood pressure (SBP) 120–139 mmHg or diastolic blood pressure (DBP) 80–89 mmHg. In the prehypertension treatment arm, participants will initiate amlodipine 5 mg daily immediately. In the standard of care arm, participants will initiate amlodipine only if they develop hypertension defined as SBP ≥ 140 mmHg or DBP ≥ 90 mmHg. The primary outcome is the difference in mean change of SBP from enrollment to 12 months. Secondary outcomes include feasibility, acceptability, adverse effects, HIV viral suppression, and medication adherence. Qualitative in-depth interviews with providers and participants will explore attitudes about initiating amlodipine, satisfaction, perceived CVD risk, and implementation challenges. Discussion PLWH have a higher CVD risk and may benefit from a lower BP threshold for initiation of antihypertensive treatment. Trial registration Clinicaltrials.gov registration number NCT04692467, registration date December 15, 2020, protocol ID 20–03021735. |
| Databáze: | OpenAIRE |
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