Defective lymphatic vasculature as a cause of fluid retention by calcium channel blocker therapy in women after menopause.

Lymphatic dysfunction as a cause of calcium channel blocker oedema in post-menopausal women

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001761-11-DK

Enrollment

Registered

2015-07-10

Start date

2015-08-31

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcium channel antagonist induced peripheral edema in post-menopausal women. We hypothesize that this condition is partly due to impaired lymphatic function in these patients. MedDRA version: 18.0 Level: LLT Classification code 10067033 Term: Drug side effect System Organ Class: 100000004867 MedDRA version: 18.0 Level: LLT Classification code 10034570 Term: Peripheral edema System Organ Class: 100000004867

Interventions

Trade Name: Amlodipin Actavis Product Name: Amlodipin "Actavis" Pharmaceutical Form: Tablet INN or Proposed INN: AMLODIPINE MESILATE MONOHYDRATE CAS Number: 440358-84-9 Current Sponsor code: 300488 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy post-menopausal women, which means that it is 1 years since last menstruation and case of flushing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: Exclusion criteria are arterial hypotension, orthostatic hypotension, angina pectoris, previous acute myocardial infarction, previous gastrointestinal bleeding, diabetes, currently in the treatment of any type of calcium channel blocker, ACE inhibitor or angiotensin-receptor blocker and allergy against anything contained in the tablets. Subjects stating unexplainable loss of consciousness during the last 5 years will also be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim with this study is to investigate the mechanism behind the oedema development often associated with treatment of cardiovascular disease with calcium channel blockers. The current belief is that a preferential arterial over venous dilation leads to increased fluid filtration. We will test this concept by measuring capillary filtration, which surprisingly has never been done before. The current belief will furthermore be challenged by also measuring the lymphatic removal of interstitial fluid during treatment with calcium channel blockers. Lymph vessels could potentially be an off-target effect of the drugs and augment oedema formation. This might explain why some patients treated with these drugs develop oedemas. ;Secondary Objective: none;Primary end point(s): Primary end-points are: lymphatic contraction frequency, contraction wave velocity, lymphatic systolic pumping pressure, the time it takes for a vessel to refill after it has been emptied by manual massage and capillary fluid filtration rate.;Timepoint(s) of evaluation of this end point: Every single end point will first be evaluated after completion of the last subject trial. 28 weeks	—

Measure

Time frame

Main Objective: The aim with this study is to investigate the mechanism behind the oedema development often associated with treatment of cardiovascular disease with calcium channel blockers. The current belief is that a preferential arterial over venous dilation leads to increased fluid filtration. We will test this concept by measuring capillary filtration, which surprisingly has never been done before. The current belief will furthermore be challenged by also measuring the lymphatic removal of interstitial fluid during treatment with calcium channel blockers. Lymph vessels could potentially be an off-target effect of the drugs and augment oedema formation. This might explain why some patients treated with these drugs develop oedemas. ;Secondary Objective: none;Primary end point(s): Primary end-points are: lymphatic contraction frequency, contraction wave velocity, lymphatic systolic pumping pressure, the time it takes for a vessel to refill after it has been emptied by manual massage and capillary fluid filtration rate.;Timepoint(s) of evaluation of this end point: Every single end point will first be evaluated after completion of the last subject trial. 28 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Denmark

Contacts

Public ContactT-forskning, Aarhus University Hosp

The Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital.

shey@clin.au.dk004550720716

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026