NCT01978132

Brief Summary

Patients with primary hyperaldosteronism experience more cardiovascular events compared to patients with primary hypertension, independent of the blood pressure level. In this research we hypothesize that patients with primary hyperaldosteronism are more susceptible to ischemia-reperfusion injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 12, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

October 31, 2013

Last Update Submit

October 11, 2017

Conditions

Primary Hyperaldosteronism

Keywords

primary hyperaldosteronismprimary hypertensionforearm ischemia-reperfusion(reduction) in brachial artery FMDendothelial ischemia-reperfusion injury

Outcome Measures

Primary Outcomes (1)

  • brachial FMD

    primary outcome measure is the reduction in brachial artery FMD after 20 minutes of forearm ischemia and 20 minutes of reperfusion in patients with primary hyperaldosteronism (compared to patients with primary hypertension)

    1 day morning

Secondary Outcomes (1)

  • CD73 and adenosine

    one day morning (just before FMD experiment)

Other Outcomes (2)

  • aldosterone and renin

    1 day

  • leukocyte telomere length (LTL)

    1 day

Study Arms (2)

Primary hyperaldosteronism

ACTIVE COMPARATOR

patients with primary hyperaldosteronism will be subjected to the intervention forearm ischemia and reperfusion (20 minutes of forearm ischemia and 20 minutes of reperfusion). Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury

Procedure: forearm ischemia and reperfusion

Primary hypertension

PLACEBO COMPARATOR

Patients with primary hypertension (PHA excluded)will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion. Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury

Procedure: forearm ischemia and reperfusion

Interventions

forearm ischemia and reperfusionPROCEDURE

both arms will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion.

Primary hyperaldosteronismPrimary hypertension

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years
  • Confirmed primary hyperaldosteronism (aldosterone \>0.28 nmol/l after salt loading)
  • Serum potassium ≥ 3.5 mmol/L (with or without potassium supplementation)
  • Written informed consent
  • Age 18-75 years
  • Primary hypertension
  • Baseline aldosterone \<0.30 nmol/l and aldosterone-renin-ratio\<0.09
  • Serum potassium ≥ 3.5 mmol/L
  • Written informed consent

You may not qualify if:

  • Smoking
  • History of atherosclerotic disease (myocardial infarction (MI), stroke, or peripheral vascular disease)
  • Not possible to change the antihypertensive medication into only diltiazem with or without hydralazine, according to the treating physician.
  • Not possible to temporarily interrupt statin treatment, if the patient use statins, according to the treating physician.
  • Severe renal dysfunction (MDRD \< 30 ml/min)
  • Second/third degree AV-block on electrocardiography
  • Cardiac failure
  • Diabetes Mellitus
  • Use of acetylsalicylic acid and NSAID's theophylline, and dipyridamole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Gelderland, 6525EZ, Netherlands

Location

MeSH Terms

Conditions

HyperaldosteronismEssential Hypertension

Interventions

Reperfusion

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativePerfusionInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

October 12, 2017

Record last verified: 2017-04

Locations

NL(1)