HEARTS Implementation for Hypertension-Diabetes Multimorbidity, Guatemala, 1,440 Adults
Summary
NIH's ClinicalTrials.gov has registered a new clinical study (NCT07536919) evaluating the WHO-developed HEARTS implementation program for comorbid hypertension and Type 2 diabetes. The pragmatic cluster-randomized trial will enroll 1,440 adults across 36 public primary care clinics in Guatemala. Participants are randomized to HEARTS intervention or current standard care, with primary outcomes (blood pressure and hemoglobin A1c) assessed at 12 months.
What changed
NIH's ClinicalTrials.gov registered a new clinical study (NCT07536919) investigating whether the WHO-developed HEARTS program improves care for patients with both hypertension and Type 2 diabetes in Guatemala. The pragmatic cluster-randomized controlled trial will recruit approximately 1,440 adults across 36 public primary care clinics, randomizing clinics to HEARTS implementation strategies and supply chain strengthening versus current standard care, with 12-month follow-up.
Healthcare providers and public health authorities involved in the study should ensure compliance with applicable clinical research regulations and Good Clinical Practice standards. The study does not impose regulatory compliance obligations on non-participating entities but provides a framework for integrating multimorbidity care in primary care settings.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation
N/A NCT07536919 Kind: NA Apr 17, 2026
Abstract
The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).
Conditions: Hypertension (HTN), Type 2 Diabetes
Interventions: HEARTS implementation strategies, Supply chain strengthening
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.