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Coronary Arteriogenetic Heparinized Exercise (CARHEXA)

C

Clinical Centre of Serbia

Status

Completed

Conditions

Refractory Angina
Chronic Stable Angina

Treatments

Other: Placebo
Other: Physical rehabilitation
Drug: Heparin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This study evaluates the addition of heparin to a 2-week cycle of physical rehabilitation in the treatment of refractory angina. Half of the patients will undergo heparin-primed physical rehabilitation, while the other half will undergo only physical rehabilitation.

Full description

Our approach is based on the combination of pharmacological stimuli (with heparin) on top of a 2-week cycle of physical rehabilitation. The rationale for this chemical-physical cocktail stems from the fact that increase in shear stress (achieved with exercise), or heparin (when used alone) have no significant effect on coronary arteriogenesis. Nevertheless, when the two stimuli are coupled coronary arteriogenesis is consistently present, and clinically significant.

The basic principle of heparin treatment is to potentiates angiogenic growth factors, which are over expressed by increased shear stress at the site of pre-existing collateral vessels as a result of exercise or pacing. Although the precise mechanisms by which heparin potentiates arteriogenesis remain to be completely elucidated, heparin administration combined with exercise has great potential in treating patients with effort angina who are not indicated for conventional revascularization therapy.

Enrollment

32 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with documented coronary artery disease not amenable of future treatment and belonging to "no-option" category with symptoms consistent with angina pectoris

Exclusion criteria

  • Patients with unstable angina, recent myocardial infarction, uncontrolled hypertension, hemodynamically valvular heart disease, bronchial asthma, and neurologic and/or orthopedic illnesses that limit exercise capacity .
  • Patients receiving vitamin K antagonist.
  • Patients actively involved in programmes of cardiac rehabilitation or exercise training.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups, including a placebo group

Heparin-primed physical rehabilitation
Experimental group
Description:
2 exercise sessions per day for 5 days a week for 2 weeks with 100 IU/kg of Heparin i.v. (up to a maximum of 5000 IU) 10 minutes prior to exercise
Treatment:
Drug: Heparin
Other: Physical rehabilitation
Placebo-primed physical rehabilitation
Placebo Comparator group
Description:
2 exercise sessions per day for 5 days a week for 2 weeks with placebo (2 ml of Sodium Chloride 0.9% i.v.) 10 minutes prior to exercise
Treatment:
Other: Placebo
Other: Physical rehabilitation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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