--- title: COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX) nct_id: NCT04409847 overall_status: COMPLETED sponsor: NHS Greater Glasgow and Clyde study_type: OBSERVATIONAL primary_condition: COVID countries: United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04409847.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04409847" ct_last_update_post_date: 2023-11-09 last_seen_at: "2026-05-12T07:30:10.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX) **Official Title:** COVID-19 Blood Pressure Endothelium Interaction Study **NCT ID:** [NCT04409847](https://clinicaltrials.gov/study/NCT04409847) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 52 - **Lead Sponsor:** NHS Greater Glasgow and Clyde - **Collaborators:** University of Glasgow - **Conditions:** COVID, Hypertension - **Start Date:** 2020-06-01 - **Completion Date:** 2021-07-01 - **CT.gov Last Update:** 2023-11-09 ## Brief Summary The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ systems, including the cardiovascular system. There are documented associations between severity of disease and risk of death and To provide all the information required by review bodies and research information systems, we ask a number of specific questions. This section invites you to give an overview using language comprehensible to lay reviewers and members of the public. Please read the guidance notes for advice on this section. 5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer). The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart failure, pulmonary embolism and disseminated intravascular coagulation. It is thought that the mechanism of action of the virus involves binding to a host transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and immune cells and cause further damage. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis. This study aims to look closely at the health of the vascular system of patients after being treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study is essential so that clinicians treating patients with high blood pressure understand the impact of the condition and these hypertension medicines in the context of the current COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients currently prescribed these medications or who are newly diagnosed with hypertension. ## Detailed Description COVID-19 is pandemic and, though it primarily affects the lungs, there is evidence of cardiovascular system involvement. Mechanistically, SARS-CoV-2, following proteolytic cleavage of its S protein by a serine protease, binds to the transmembrane angiotensin-converting enzyme 2 (ACE2) -a homologue of ACE-to enter type 2 pneumocytes, macrophages, perivascular pericytes, and cardiomyocytes. This may lead to myocardial dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque instability, and myocardial infarction. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers alter prognosis. ## Eligibility - **Minimum age:** 30 Years - **Maximum age:** 60 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Admission between 01/04/2020 and 31/12/2020 Clinically suspected or PCR confirmed COVID-19 Age 30-60 years No history of hypertension or current drug treatment for hypertension Exclusion Criteria: * Inability to give informed consent/lack of capacity Non-English speakers BMI \>40 eGFR \<60 ml/min Pregnancy History of Cancer within 5 years Persistent atrial fibrillation Severe illness, at investigator discretion Prescription of BP lowering drugs Corticosteroid (chronic use) Immunosupressive agents NSAIDs (chronic use) ``` ## Arms - **COVID+ PCR** — Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19 - **COVID- PCR** — subjects admitted with COVID-19 like symptoms but are SARS-CoV-2 PCR-ve and have CXR or CT chest that show low probability of COVID-19 will form the control group ## Interventions - **ABPM** (DIAGNOSTIC_TEST) — 24 hour ambulatory blood pressure monitoring - **ECG** (DIAGNOSTIC_TEST) — Electrocardiogram - **FMD** (DIAGNOSTIC_TEST) — Flow mediated dilatation - **PWV** (DIAGNOSTIC_TEST) — Pulse wave velocity - **Rarefaction** (DIAGNOSTIC_TEST) — nailbed capillaroscopy ## Primary Outcomes - **ABPM systolic blood pressure** _(time frame: 24 hours (all day and night))_ — Ambulatory Blood Pressure Monitoring systolic blood pressure ## Secondary Outcomes - **24-hr ABPM DBP** _(time frame: 24 hours (all day and night))_ - **day ABPM SBP** _(time frame: 8am to 8pm)_ - **day ABPM DBP** _(time frame: 8am to 8pm)_ - **night ABPM SBP** _(time frame: 8pm to 8am)_ - **night ABPM DBP** _(time frame: 8pm to 8am)_ - **dipping status** _(time frame: 24 hours (all day and night))_ - **morning surge** _(time frame: 24 hours (all day and night))_ - **24 hour ABPM HR** _(time frame: 24hr (all day and night))_ - **day ABPM HR** _(time frame: 8 am to 8 pm)_ - **night ABPM HR** _(time frame: 8pm to 8 am)_ - **Immune phenotyping** _(time frame: at baseline)_ - **Microparticle assessments** _(time frame: at baseline)_ ## Locations (1) - NHS Greater Glasgow and Clyde, Glasgow, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.nhs greater glasgow and clyde|glasgow||united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04409847.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04409847* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*