Mortality Outcome of Controlled Hypertension

NCT07187596 — Active not recruiting, 2547 participants, DejthidaNathaphong

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Progressive Elaboration Framework of Mortality Outcomes in Controlled Hypertension: A Qualitative Evidence Synthesis Systematic Review and Individual Participant Data Meta-Analysis 1

RegistryNCT07187596, acronym MOCH1
StatusActive not recruiting
Study typeObservational
Enrollment2547 (Estimated)
SponsorDejthidaNathaphong (Other)
ConditionsHypertension, Morality, Death, Pre-Eclampsia, Cardiovascular Diseases, Stroke, Renal Disease, Artery Stenosis, Arterial Aneurysm, Arterial Rupture, Maternal Death
Datesstart 2025-09-18, primary completion 2026-12-18 (estimated), completion 2027-12-14 (estimated), first posted 2025-09-23, last updated 2026-07-29
Locations1 site in Thailand

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-Summary

This review focuses on the assumption of mortality outcome of participants remaining label hypertension care is adequately managed when pressure targets are met with both qualitative and quantitaive method.

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+Detailed description

For systematically review and synthesize the literature on main 2 questions

1. Why do mortality outcomes still occur despite intervention of high blood pressure?
2. What is the framework of high blood pressure death?

For Individual Participant Data Meta-analysis will be attracted from final analysis articles from the framework of data selection process only, the effect measurement and multi-variable model meta-analysis will be performed.

Sub-group analysis effect measurement following;

* Types and causes of death in patients with well-controlled hypertension.
* Underlying evidence or proposed mechanisms, biological markers, or comorbid conditions contribute to death despite optimal treatment.
* Treatment-related limitations, co-factors, and syndromes leading to uncontrolled fatal outcomes.
* Analyze possible mechanisms of cardiovascular death in controllable even intensive blood pressure control participants.

+Arms and interventions

ArmTypeInterventionsDescription
Mortality outcomesMortality outcomes or casue which mainly suspected from hypertension

+Outcome measures

Primary outcomes

  • All-cause vascular mortality [Day one until last follow up at least 24 hour to study completion date at least 30 days outcomes but not over 10 years]: Cardiovascular mortality (Cardiac-related death in controlled hypertension patients), cerebrovascular death(Stroke-related fatal outcomes in BP-controlled patients), renal occlusion/rupture/failure causing death (Mortality from renal failure in treated, controlled hypertensives), life-threatening vascular rupture, Major Adverse Cardiovascular Death or

Secondary outcomes

  • Sudden death [Day one until last follow up at least 24 hour to study completion date at least 30 days outcomes but not over 10 years]: Death suddenly with autopsy or complete CPR during collapse of cardiac or respiratory or brain arrested
  • End-organ failure leading to death [90 days outcomes after participant recruitment (death/alive)]: Vascular abnormality causing failure of organ leading death with evidence by imaging, laboratory investigation or autopsy
  • ICU death [90 days outcomes start with day 1 admit at ICU (death/alive)]: Systemic arterial hypertension is the main reason for admission at critical care unit report death
  • Maternal associated hypertension death [During pregnancy period from GA 1 week to delivery (pre-term, term-post-term) to 6 week follow up postpartum]: Mortality outcomes of hypertension during pregnancy both from gynecologic organ failure or systemic organ failure
  • Hypertension associated death in the young [Day one until last follow up at least 24 hour to study completion date at least 30 days outcomes but not over 18 years of ages of participant]: Mortality outcomes that clear defined high blood pressure of that age and declared mortality cause during or after any type of treatment

+Eligibility

Sex: All, ages: 1 Minute to 130 Years

* Inclusion:

  * Human birth in all sex chromosomes.
  * Study reports evidence of living with owned systemic/arterial hypertension by one of definition following;

    * Quantitative: Blood pressure number higher over the normal range by each protocol in mmHg unit in any arm of study.
    * Qualitative: Clarify the underwent both retrospective, observation or intervention of blood pressure and clearly clarify number of hypertension participants in article.
  * Study design: any type of studies and have a doi number.

    * In case report type study, the article recruit in only high blood pressure is a burden that reports both direct intervention for blood pressure or indirect intervention such as treatment of vascular damage from high blood pressure.
    * In a group of literature review type study, the number of hypertension participants with references from both in supplementary document or traced back via each doi number have to clearly declare in that free full-text and currently non-retracted article without personal requirement as raw material to processing the individual participant data meta-analysis
  * Study recruit only last version of study series that have to confirm published the hypertension participant with mortality outcomes.
  * English-language studies.
* Exclusion:

  * Non human/human-specimen studies.
  * Evidence confirms local site or specific system hypertension only such as studies of pulmonary hypertension, portal hypertension, ocular hypertension without clearly defining the number of systemic arterial hypertension in articles.
  * No report of conclusion of participant such as no mortality report, no failed/successful outcome from last follow up from hypertension associated life-threatening event.
  * Deaths due to suicide, trauma, or illegal drugs including intend to take medication overdose in any reason.
  * Book, Testimonial, Interview, Conference, Protocol articles.
  * Sub-group analysis.
  * Duplicate one of the doi/nct/prospero numbers.
  * No doi. Number

+Locations (1)

FacilityCityCountryStatus
Owned studyBangkok, BangkokThailand

+Study documents

+Investigators